OptumHealth Care Solutions LLC: Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump

Hazard

Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing.

Details from the source

Reason for recall: Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing. Distribution: US Nationwide Distribution Quantity: 208 units Lot/code info: UDI/DI 00862492000308, Each unit has a Lot Number and a Serial Number, listed as follows: Lot Number/Serial Number: 302604 / NIMBP702231, 318050 / NIMBP715656, 340086 / NIMBS718475, 340163 / NIMBS716926, 340648 / NIMBS716122, 340746 / NIMBS715845, 340820 / NIMBS712929, 340903 / NIMBP719704, 341046 / NIMBS713994, 341372 / NIMBS718513, 341535 / NIMBS718700, 341757 / NIMBS716661, 341770 / NIMBS716996, 342136 / NIMBS715836, 342233 / NIMBS718503, 342350 / NIMBS714995, 342447 / NIMBS713444, 342938 / NIMBS716864, 343066 / NIMBS716125, 343309 / NIMBS719492, 343683 / NIMBS716506, 344023 / NIMBS716532, 344044 / NIMBS718477, 344173 / NIMBS718500, 344273 / NIMBS715037, 344407 / NIMBS709122, 344440 / NIMBS709111, 344450 / NIMBS708973, 344455 / NIMBS709568, 344572 / NIMBS709989, 344588 / NIMBS708676, 344692 / NIMBS709563, 344783 / NIMBS709112, 344853 / NIMBS709482, 344862 / NIMBS709556, 344976 / NIMBS709267, 345057 / NIMBS716989, 345060 / NIMBS716509, 345190 / NIMBS708707, 345195 / NIMBS719668, 345396 / NIMBS718671, 345397 / NIMBS708966, 345443 / NIMBS716367, 345446 / NIMBS719686, 345728 / NIMBS718488, 345732 / NIMBS716946, 345774 / NIMBS716166, 345872 / NIMBS709020, 345879 / NIMBS716159, 346002 / NIMBS716398, 346156 / NIMBS710038, 346167 / NIMBS709114, 346318 / NIMBS709337, 346410 / NIMBS715276, 346634 / NIMBS709569, 346636 / NIMBS709080, 346638 / NIMBS717005, 346642 / NIMBS716878, 346643 / NIMBS709550, 346947 / NIMBS709316, 347056 / NIMBS718701, 347173 / NIMBS716827, 347296 / NIMBS717651

UPC codes

00862492000308

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.